Last Updated: June 27, 2026

Details for New Drug Application (NDA): 213966

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NDA 213966 describes DAPTOMYCIN, which is a drug marketed by Accord Hlthcare, Aspiro, Be Pharms, Biocon Pharma, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly Pharm, Hangzhou Zhongmei, Hengrui Pharma, Hikma, Hisun Pharm Hangzhou, Hospira, Maia Pharms Inc, Meitheal, Mylan, Mylan Labs Ltd, Qilu Pharm Hainan, Sagent Pharms Inc, Teva Pharms Usa, Xellia Pharms Aps, and Baxter Hlthcare Corp, and is included in thirty-one NDAs. It is available from twenty-five suppliers. There are four patents protecting this drug. Additional details are available on the DAPTOMYCIN profile page.

The generic ingredient in DAPTOMYCIN is daptomycin. There are ten drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 213966

Tradename:	DAPTOMYCIN
Applicant:	Mylan
Ingredient:	daptomycin
Patents:	0

Pharmacology for NDA: 213966

Medical Subject Heading (MeSH) Categories for 213966

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 213966

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DAPTOMYCIN	daptomycin	POWDER;INTRAVENOUS	213966	ANDA	Mylan Institutional LLC	67457-941	67457-941-15	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-941-15) / 10 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Aug 7, 2023	TE:	AP	RLD:	No

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